| CTRI Number |
CTRI/2024/01/062069 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To understand the Impact of exercises during dialysis in patients with end stage Chronic Kidney Disease (CKD) |
|
Scientific Title of Study
|
Impact of Renal rehabilitation through intra dialytic exercises in patients with end stage Chronic Kidney Disease (CKD) on hemodialysis – a prospective randomized control study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saril V S |
| Designation |
Consultant, Assistant General Manager |
| Affiliation |
Sakra World Hospital |
| Address |
Sakra World Hospital
Sy No 52 2 and 52 3 Devarabeesanahalli
Varthur Hobli
Bangalore
India
Bangalore
KARNATAKA
560103
India |
| Phone |
7406800418 |
| Fax |
|
| Email |
sarilvs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saril V S |
| Designation |
Consultant, Assistant General Manager |
| Affiliation |
Sakra World Hospital |
| Address |
Sakra World Hospital
Sy No 52 2 and 52 3 Devarabeesanahalli
Varthur Hobli
Bangalore
India
Bangalore
KARNATAKA
560103
India |
| Phone |
7406800418 |
| Fax |
|
| Email |
sarilvs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saril V S |
| Designation |
Consultant, Assistant General Manager |
| Affiliation |
Sakra World Hospital |
| Address |
Sakra World Hospital
Sy No 52 2 and 52 3 Devarabeesanahalli
Varthur Hobli
Bangalore
India
Bangalore
KARNATAKA
560103
India |
| Phone |
7406800418 |
| Fax |
|
| Email |
sarilvs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sakra World Hospital, Bangalore |
|
|
Primary Sponsor
|
| Name |
Sakra World Hospital |
| Address |
Sy No 52-2 and 52-3, Devarabeesanahalli, Varthur Hobli, Bangalore 560103 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSarilVS |
Sakra World Hospital, Bangalore |
Sakra Institute of Rehabilitation Sciences, 3rd floor C wing, Sakra World Hospital, Sy No 52-2 and 52-3, Devarabeesanahalli, Varthur Hobli, Bangalore 560103
Bangalore
KARNATAKA |
7406800418
sarilvs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee Sakra World Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active cycling using pedocycle |
30-45 minutes 3 times per week during dialysis |
| Intervention |
Diaphragmatic breathing exercise |
10 X 2, 3 times per week |
| Intervention |
Inspiratory Muscle Training |
30 repetitions 3 times per week during dialysis
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age group more than 18 years
Patients with end stage Chronic Kidney Disease(CKD) undergoing hemodialysis
Patients who are able to stand and walk
|
|
| ExclusionCriteria |
| Details |
Patients with unstable haemodynamic parameters
Symptomatic ischemic heart disease
Patient undergone any recent surgeries
Patients with cognitive impairment
Lower limb amputation
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functional capacity 6 Minute Walk Test
Inspiratory muscle strength
|
Baseline, 3months and 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kidney Quality of Life |
Baseline, 3months & 6months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
· Chronic kidney diseases (CKD), worldwide, are rising markedly and becoming a priority public health problem. · The progression of CKD causes functional limitation and severe disability with poor quality of life (Domenico Intiso, 2014). Chronic Kidney Diseases are the 6th fastest cause of death and suffering due to high morbidity · Renal rehabilitation (RR) is a coordinated, multifaceted intervention designed to optimize a patient’s physical, psychological, and social functioning, in addition to stabilizing, slowing, or even reversing the progression of renal deterioration, thereby reducing morbidity and mortality (Masahiro Kohzuki, 2013) - Intradialytic exercise is a recommendation given to encourage renal patients to be physically active. Studies have suggested that intradialytic exercise is effective in reducing fatigue severity, improving sleep quality, enhancing exercise tolerance, improving quality of life. Research also indicates that intradialytic exercise can increase the efficacy of dialysis, subsequently alleviating inflammation, improving nutrition and bone mineral density. (Pu J, et al. BMJ Open 2019)
1. Research Objective: To compare the effects of supervised intradialytic exercises (Experimental Group) Versus conventional care (Control Group) in patients with end stage Chronic Kidney Disease (CKD) who undergo hemodialysis 2. Rationale: There has been evidence that Intradialytic Rehabilitation (IDR) helps to improve a patient’s overall functional status and quality of life. However, such intervention is not practiced in India and there is a dearth of clinical studies done on Indian population. |